Trial · NCT01032382
Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK)
NCT01032382, Phase 2, Completed, U.S. Army Medical Research and Development Command; results first posted 2014-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK). Trials, record NCT01032382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01032382
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK)
- NCT number
- NCT01032382
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Conditions
- Leishmaniasis, Cutaneous
- Interventions
- WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream), Paromomycin Alone Cream (15% paromomycin topical cream)
- First posted
- 2009-12-15
- Last updated
- 2015-07-16
- Results first posted
- 2014-08-22
- Limitations and caveats
All randomized subjects were included in the mITT analysis. All subjects also met the criteria for the evaluable subset; therefore, no separate analysis of an evaluable subset of subjects was performed.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Final Clinical Cure for Index Lesions | Initial clinical cure by day 63 and no relapse by day 168 | Final clinical cure was defined as follows: 1. Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR, 2. Subject has initial clinical improvement (\> 50% re-epithelialization of index lesion by nominal Day 63 followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND, 3. Subject has no relapse of index lesion by Day 168. Relapse was defined as an index lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (\> 0 x 0 mm measurement) by nominal day 168, or an index lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168. |
| Secondary | Detectable Paromomycin Plasma Levels | Day 4, 7, 12, 17, 20, 28 | Paromomycin plasma concentrations following administration of paromomycin alone or WR 279,396 in adults |
| Secondary | Paromomycin Plasma Concentrations in Children | 0 and 4 hours on days 1 and 20 | Paromomycin plasma concentrations 4 hours following administration of paromomycin alone or WR 279,396 in children |
| Secondary | Pharmacokinetic Parameter: Cmax | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Cmax of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Secondary | Pharmacokinetic Parameter: Tmax | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Pharmacokinetic Parameter: Tmax |
| Secondary | Pharmacokinetic Parameter: Area Under the Curve (AUC) | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Area under the curve (AUC) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Secondary | Pharmacokinetic Parameter: t(1/2) | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | t(1/2) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Secondary | Pharmacokinetic Parameter: Cmax/D | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Maximum observed plasma concentration divide by topical dose (Cmax/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Secondary | Pharmacokinetic Parameter: AUC/D | Days 1 and 20 | Area under the plasma concentration-time curve over 24 hrs divided by topical dose (AUC/D) of paromomycin following administration of paromomycin alone or WR 279,396 to adults in Panama |
| Secondary | Final Clinical Cure on All Lesions Independent of Subjects | Initial clinical cure by day 63 and no relapse by day 168 | Final clinical cure was defined as follows: 1. Subject has initial clinical cure (100% re-epithelialization of lesion by nominal Day 63); OR, 2. Subject has initial clinical improvement (\> 50% re-epithelialization of lesion by nominal Day 63 followed by 100% re-epithelialization of the lesion on or before nominal Day 100; AND, 3. Subject has no relapse of lesion by Day 168. Relapse was defined as a lesion meeting the criteria for initial clinical cure that had any new ulceration/nodule (\> 0 x 0 mm measurement) by nominal day 168, or a lesion meeting the criteria for initial clinical improvement that subsequently enlarged by nominal Day 168. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Final Clinical Cure for Index Lesions | Initial clinical cure by day 63 and no relapse by day 168 | participants | NUMBER | |
| SECONDARY | Detectable Paromomycin Plasma Levels | Day 4, 7, 12, 17, 20, 28 | Adults (18+ years) | ng/mL | MEAN |
| SECONDARY | Paromomycin Plasma Concentrations in Children | 0 and 4 hours on days 1 and 20 | Children ages 5 to 17 (inclusive) | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Cmax | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults (18+ years) | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Tmax | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults (18+ years). On day 1, Paromomycin Alone Treatment group N = 4; WR 279,396 group N = 3. | hr | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Area Under the Curve (AUC) | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults (18+ years) | ng*hr/mL | MEAN |
| SECONDARY | Pharmacokinetic Parameter: t(1/2) | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults (18+ years). WR 279,396 group measurements Day 1 N = 2 and Day 20 N = 4. One study participant in the Paromomycin Alone Treatment was withdrawn at Day 100. | hr | MEAN |
| SECONDARY | Pharmacokinetic Parameter: Cmax/D | 0, 0.5, 1.0, 2.0, 3.0, 4.0, 8.0, 12.0, 24.0 hours on both Days 1 and 20 | Adults (18+ years) | 1/ML | MEAN |
| SECONDARY | Pharmacokinetic Parameter: AUC/D | Days 1 and 20 | Adults (18+ years) | hr/ML | MEAN |
| SECONDARY | Final Clinical Cure on All Lesions Independent of Subjects | Initial clinical cure by day 63 and no relapse by day 168 | Cured ulcerated lesions | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Final Clinical Cure for Index Lesions | Paromomycin Alone Treatment | 11 | participants | ||
| Final Clinical Cure for Index Lesions | WR 279,396 | 9 | participants | ||
| Detectable Paromomycin Plasma Levels | Paromomycin Alone Treatment | Day 4 | 12.1 | Standard Deviation 27.0 | ng/mL |
| Detectable Paromomycin Plasma Levels | WR 279,396 | Day 4 | 37.3 | Standard Deviation 74.5 | ng/mL |
| Detectable Paromomycin Plasma Levels | Paromomycin Alone Treatment | Day 7 | 10.3 | Standard Deviation 23.1 | ng/mL |
| Detectable Paromomycin Plasma Levels | WR 279,396 | Day 7 | 17.9 | Standard Deviation 35.8 | ng/mL |
| Detectable Paromomycin Plasma Levels | Paromomycin Alone Treatment | Day 12 | 36.2 | Standard Deviation 33.2 | ng/mL |
| Detectable Paromomycin Plasma Levels | WR 279,396 | Day 12 | 78.9 | Standard Deviation 81.6 | ng/mL |
| Detectable Paromomycin Plasma Levels | Paromomycin Alone Treatment | Day 17 | 210.0 | Standard Deviation 327.0 | ng/mL |
| Detectable Paromomycin Plasma Levels | WR 279,396 | Day 17 | 162.0 | Standard Deviation 123.0 | ng/mL |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paromomycin Alone Treatment | 16 | |
| Overall Study | STARTED | WR 279,396 | 14 | |
| Overall Study | COMPLETED | Paromomycin Alone Treatment | 11 | |
| Overall Study | COMPLETED | WR 279,396 | 9 | |
| Overall Study | NOT COMPLETED | Paromomycin Alone Treatment | 5 | |
| Overall Study | NOT COMPLETED | WR 279,396 | 5 |
Source ClinicalTrials.gov
Adverse events106
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymph node pain | Blood and lymphatic system disorders | Paromomycin Alone Treatment | 0 | 16 | |
| other | Lymph node pain | Blood and lymphatic system disorders | WR 279,396 | 1 | 14 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Paromomycin Alone Treatment | 3 | 16 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | WR 279,396 | 2 | 14 | |
| other | Motion sickness | Ear and labyrinth disorders | Paromomycin Alone Treatment | 0 | 16 | |
| other | Motion sickness | Ear and labyrinth disorders | WR 279,396 | 1 | 14 | |
| other | Bleeding anovulatory | Endocrine disorders | Paromomycin Alone Treatment | 0 | 16 | |
| other | Bleeding anovulatory | Endocrine disorders | WR 279,396 | 1 | 14 | |
| other | Conjunctivitis allergic | Eye disorders | Paromomycin Alone Treatment | 1 | 16 | |
| other | Conjunctivitis allergic | Eye disorders | WR 279,396 | 1 | 14 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paromomycin Alone Treatment | ||
| Total, all-cause mortality | WR 279,396 | ||
| Total, other adverse events | Paromomycin Alone Treatment | 16 | 16 |
| Total, other adverse events | WR 279,396 | 14 | 14 |
| Total, serious adverse events | Paromomycin Alone Treatment | 0 | 16 |
| Total, serious adverse events | WR 279,396 | 0 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23877689 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Paromomycin Alone Treatment vs WR 279,396: Final Clinical Cure for Index Lesions | Trial comparisons |
| Paromomycin Alone Treatment vs WR 279,396: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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